RecruitingNCT07124754

Multimodal Deep Learning for Lymph Node Metastasis Prediction and Physician Performance Assessment in T1 Gastric Cancer

Development and Validation of a Multimodal Artificial Intelligence Model for Predicting Lymph Node Metastasis in T1 Gastric Cancer and Its Impact on Physician Diagnostic Performance


Sponsor

Qun Zhao

Enrollment

300 participants

Start Date

Jan 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

This study aims to develop and validate an artificial intelligence (AI) model that integrates clinical, pathological, and imaging data to predict the presence of lymph node metastasis (LNM) in patients with T1-stage gastric cancer. The study will also compare the diagnostic performance of physicians with and without AI assistance, including clinicians with varying levels of experience. The goal is to improve early decision-making and support more personalized treatment strategies for patients with early gastric cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an AI system that uses multiple types of data (including scans, lab results, and tissue samples) to predict whether early-stage stomach cancer (T1 gastric cancer) has spread to nearby lymph nodes, which is critical for deciding whether surgery or a less invasive procedure is needed. **You may be eligible if...** - You are 18 years or older - You have confirmed early-stage stomach cancer (T1a or T1b) based on endoscopy and imaging - You have had stomach cancer confirmed by biopsy (gastric adenocarcinoma) - You are scheduled to undergo surgery (radical gastrectomy with lymph node removal) - Pre-operative data including CT scans and pathology slides are available **You may NOT be eligible if...** - You have a history of other cancers - Your cancer is more advanced than T1 stage - You lack the necessary pre-operative data for the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTMultimodal Artificial Intelligence Diagnostic Model for Lymph Node Metastasis in T1 Gastric Cancer

This intervention involves the use of a custom-built artificial intelligence (AI) diagnostic model that integrates multimodal data-including clinical variables, histopathological features, and imaging data-to predict lymph node metastasis in patients with T1-stage gastric cancer. The model provides risk probability scores and classification outputs that assist physicians in diagnostic decision-making. The AI system will be compared with physician performance at different levels of experience (resident, attending, senior) to assess its impact on diagnostic accuracy and clinical decision support.


Locations(1)

the Fourth Hospital of Hebei Medical University

Shijiazhuang, None Selected, China

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NCT07124754